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临床试验/CTRI/2024/05/067346
CTRI/2024/05/067346尚未招募不适用

Role of Ankle Brachial Pressure Index in the early diagnosis of Peripheral Vascular Disease in asymptomatic diabetic patients

Dr Aishwarya Solanki1 个研究点 分布在 1 个国家目标入组 203 人开始时间: 2024年5月24日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
203
试验地点
1
主要终点
To Detect Peripheral Vascular Disease in asymptomatic diabetic patients using Ankle Brachial Pressure Index

研究概览

简要总结

Patients diagnosed as having Type 2 Diabetes Mellitus by a physician or patients on treatment for diabetes who don’t have symptoms of peripheral vascular disease will be approached in the OPD and Wards of both participating departments of general surgery and general medicine for participating in the study, will be explained the details of the study. Once the patient agrees, informed written consent will be taken. The case will then be recruited into the study. Basic demographic details will be obtained. We will assess the patients for duration of diabetes mellitus, other co morbidities, symptoms of peripheral neuropathy, history of Myocardial Infarction, HbA1c levels if available, family history of peripheral or coronary artery disease. Patient will then be asked to lie supine on bed and Systolic BP will be measured in both upper limbs and both lower limbs using sphygmomanometer with appropriate cuffs and handheld doppler device. The process will take about 10-20 minutes. The values will be charted in the Data collection proforma and Ankle Brachial Pressure Index will be calculated. Based on the obtained value and if the patient has ABPI<0.9, they’ll be counselled to go to concerned doctors for workup and further management of Peripheral vascular disease . If arterial doppler is done on the same admission, information will be obtained regarding the same. There will be no Follow up of the patients.

研究设计

研究类型
Observational

入排标准

年龄范围
30.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1 All Type 2 diabetic patients from the OPD and wards in Dept of General Surgery & Dept of General Medicine who do not have PVD symptoms or signs like Active ulcers Absent peripheral pulses Intermittent Claudication Rest Pain Skin changes like cold, shiny skin Loss of hair on legs Thickened or opaque toe nails Gangrene 2 Previous healed ulcers 3 Patients giving consent to participate in the study.
  • 4 Patients greater than 30 years of age.
  • 5 Patients of both the genders.
  • 6 Patients with peripheral neuropathy symptoms.
  • 7 Patients with previous History of Myocardial Infarction, Stroke, TIA, CKD.
  • 8 Patients with family history of arterial disease.

排除标准

  • 1 Type 2 Diabetic patients who have already developed any symptoms suggestive of PVD.
  • 2 Patients lesser than 30 years of age.
  • 3 Patients with previous amputations 4 Patients with active ulcers.

结局指标

主要结局

To Detect Peripheral Vascular Disease in asymptomatic diabetic patients using Ankle Brachial Pressure Index

时间窗: The Ankle Brachial Pressure Index will be measured at the time of first contact with the patient in the OPD or ward, i.e. at Baseline only, which will take approximately 15-20 minutes. There will be no follow up of the patient.

次要结局

  • To determine prevalence of PVD among Asymptomatic Diabetic Patients(After the sample size is reached in 18 months , prevalence of PVD among the diabetic patient will be calculated.)

研究者

发起方
Dr Aishwarya Solanki
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Aishwarya Solanki

Department of General Surgery, Kasturba Medical College , Manipal

研究点 (1)

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